Aimed at increasing supply during the COVID-19 pandemic, Mylan N.V. (MYL -3.9%) has waived its exclusive U.S. distribution rights for a generic version of AbbVie’s (ABBV +2.8%) HIV antiviral combo pill Kaletra (lopinavir/ritonavir).
Its action enables other generic firms to apply for U.S. approval.
It will earn a 180-day period of market exclusivity for being the first to file and (presumably) the first to receive an FDA nod for the tablet formulation (application currently under agency review).
The FDA approved Lannett Company’s (LCI -2.7%) generic oral solution formulation in January 2017.
Gilead Sciences (GILD -3.1%) has submitted a request to the FDA to rescind Orphan Drug status for antiviral remdesivir for COVID-19, a designation granted by the agency only two days ago.
The company says it can maintain an expedited timeline for regulatory review without the designation which is intended to apply for diseases affecting no more than 200K Americans.
According to Johns Hopkins Case Tracker, confirmed U.S. coronavirus cases now total 55,568 (+8,763 from yesterday).
CytoSorbents (CTSO +23.4%) is up in early trade on almost a 5x surge in volume in response to an update from CEO Phillip Chan, M.D., Ph.D., who says that healthcare providers in Italy, China, Germany and France have used its CytoSorb blood purification device in more than 70 critically ill COVID-19 patients to help treat cytokine storm and potentially life-threatening complications like acute respiratory syndrome and shock, adding that preliminary verbal reports have been “generally associated” with marked reductions in cytokine storm (out-of-control immune response) and inflammation, improved lung function, weaning from mechanical ventilation and reversal of shock.
CytoSorb is approved in the EU and is distributed in 58 countries around the world. It is not yet available in the U.S.
BeiGene (NASDAQ:BGNE) announces a supply disruption in Abraxane (nanoparticle albumin-bound paclitaxel) due to the suspension of importation instituted by the China National Medical Products Administration. The agency took action after inspecting Bristol-Myers Squibb’s (NYSE:BMY) manufacturing facility in the U.S. that, apparently, identified certain deficiencies.
BeiGene says it its working closely with BMY to restore supply via remediation efforts at the U.S. location. It has also submitted an application in China to qualify an alternative manufacturing site.
BMY’s Celgene (NASDAQ:CELG) supplies the product to BGNE under a 2017 agreement.
Vir Biotechnology (NASDAQ:VIR) has in-licensed non-exclusive rights to Xencor’s (NASDAQ:XNCR) Xtend Fc technology aimed at extending the half-lives of novel antibodies it is investigating for the potential treatment of COVID-19.
Under the terms of the agreement, Vir will be responsible for all R&D, regulatory and commercial activities. Specific financial terms are not disclosed.
Xencor’s Xtend XmAb Fc domains increase circulating half-life by increasing binding affinity to a receptor called FcRn which is present inside lysosomes in epithelial cells lining blood vessels. They “rescue” antibodies from the degradation that make most proteins short-lived in circulation.
